【摘要】 目的 探讨任督阴阳调和针刺法联合补气宁心方治疗心脾两虚型失眠患者的临床效果。方法 选取2022年5月至2024年2月商丘市中医院收治的183例失眠(心脾两虚型)患者纳入研究，按随机数表法分为针刺组、汤剂组和联合组，每组61例。针刺组患者采用任督阴阳调和针刺法治疗，汤剂组患者采用补气宁心方治疗，联合组患者采用任督阴阳调和针刺法联合补气宁心方治疗，均治疗2个疗程(20 d)。治疗2个疗程后比较三组患者的疗效，以及治疗前后的中医证候积分、病情相关评分[匹兹堡睡眠质量指数(PSQI)量表评分、失眠严重程度指数量表(ISI)评分]、脑血流指标[双椎椎动脉收缩峰血流速度(VASP)、基底动脉收缩峰血流速度(PSBV)]、血清神经递质与炎症指标[5-羟色胺(5-HT)、γ-氨基丁酸(GABA)、肿瘤坏死因子-α (TNF-α)、白细胞介素-1β (IL-1β)]水平，同时比较两组患者随访1个月后复发率和不良反应发生率。结果 联合组患者的治疗总有效率为96.72%，明显高于针刺组的78.69%和汤剂组的86.89%，差异有统计学意义(P<0.05)，而针刺组与汤剂组患者的治疗总有效率比较差异无统计学意义(P>0.05)；联合组患者治疗后入睡困难、多梦易醒、心悸、健忘、神疲乏力、头晕目眩、腹胀食少中医证候积分均明显低于汤剂组和针刺组患者，而汤剂组患者上述各项中医证候积分均明显低于针刺组患者，差异均有统计学意义(P<0.05)；治疗后联合组患者的PSQI、ISI评分分别为(5.15±0.84)分、(6.23±1.47)分，明显低于汤剂组的(7.00±1.05)分、(8.19±1.78)分和针刺组的(9.04±0.52)分、(12.00±2.53)分，而汤剂组患者PSQI、ISI评分均低于针刺组患者，差异均有统计学意义(P<0.05)；治疗后联合组患者VASP、PSBV分别为(66.42±9.00) cm/s、(76.34±13.59) cm/s，明显快于针刺组的(60.78±7.56) cm/s、(69.58±8.76) cm/s和汤剂组的(53.65±11.24) cm/s、(60.03±12.27) cm/s，且针刺组患者的VASP、PSBV明显快于汤剂组，差异均有统计学意义(P<0.05)；联合组患者治疗后的GABA、5-HT水平明显高于汤剂组和针刺组，IL-1β、TNF-α水平则明显低于汤剂组和针刺组，而汤剂组患者治疗后的GABA、5-HT水平明显高于针刺组，IL-1β、TNF-α明显低于针刺组，差异均有统计学意义(P<0.05)；联合组患者随访1个月的复发率为3.28%，明显低于针刺组的18.03%和汤剂组的13.11%，差异有统计学意义(P<0.05)，但针刺组与汤剂组患者随访1个月的复发率比较差异无统计学意义(P>0.05)；三组患者的不良反应发生率比较差异均无统计学意义(P>0.05)。结论 任督阴阳调和针刺法联合补气宁心方治疗心脾两虚型失眠患者疗效显著，其可有效改善患者的脑血流、炎症状态，调节神经递质，减轻临床症状及失眠程度，提升睡眠质量，降低复发率。更多还原

【Abstract】 Objective To investigate the clinical effect of Rendu Yin-Yang Harmonization Acupuncture(acupuncture therapy of regulating yin and yang) combined with Qi-nourishing and Heart-calming Formula(the prescription of nourishing qi and calming the heart) in the treatment of insomnia patients of heart and spleen deficiency type. Methods A total of 183 patients with insomnia(with deficiency of both the heart and spleen) admitted to Shangqiu Hospital of Traditional Chinese Medicine from May 2022 to February 2024 were selected for inclusion in the study. They were randomly divided into an acupuncture group, a decoction group, and a combined group according to a random number table method, with 61 patients in each group. Patients in the acupuncture group were treated with Rendu Yin-Yang Harmonization Acupuncture, patients in the decoction group were treated with the Qi-nourishing and Heart-calming Formula, and patients in the combined group were treated with the Rendu Yin-Yang Harmonization Acupuncture combined with the Qi-nourishing and Heart-calming Formula. All patients were treated for two courses(20 days). After treatment, the efficacy among the three groups of patients was compared, as well as the scores of traditional Chinese medicine(TCM) syndromes, disease-related scores(Pittsburgh Sleep Quality Index [PSQI] scale score,Insomnia Severity Index [ISI] score), cerebral blood flow indicators(peak systolic velocity of bivertebral artery[VASP], peak systolic velocity of basilar artery [PSBV]), serum neurotransmitters and inflammatory indicators(5-hydroxytryptamine [5-HT], γ-aminobutyric acid [GABA], tumor necrosis factor-α [TNF-α], interleukin-1β [IL-1β]), and the recurrence rate and adverse reaction rate of the two groups of patients after one month of follow-up. Results The total effective rate of the combined group was 96.72%, which was significantly higher than that of the acupuncture group(78.69%) and the decoction group(86.89%), with statistically significant differences(P<0.05). However, there was no significant difference in the total effective rate between the acupuncture group and the decoction group(P>0.05). After treatment, the scores of traditional Chinese medicine(TCM) symptoms such as difficulty falling asleep, dreaminess and easy awakening, palpitations, forgetfulness, fatigue, dizziness, abdominal distension, and reduced appetite in the combined group were significantly lower than those in the decoction group and acupuncture group. However, the scores of the above TCM symptoms in the decoction group were significantly lower than those in the acupuncture group, and the differences were statistically significant(P<0.05). After treatment, the PSQI and ISI scores of patients in the combined group were(5.15±0.84) points and(6.23±1.47) points, respectively, which were significantly lower than(7.00±1.05) points and(8.19±1.78) points of the decoction group and(9.04±0.52) points and(12.00±2.53) points of the acupuncture group, respectively; the PSQI and ISI scores of patients in the decoction group were significantly lower than those of patients in the acupuncture group; the differences were statistically significant(P<0.05). After treatment, the VASP and PSBV of patients in the combined group were(66.42 ±9.00) cm/s and(76.34 ± 13.59) cm/s, which were significantly faster than(60.78±7.56) cm/s and(69.58±8.76) cm/s of the acupuncture group and(53.65±11.24) cm/s and(60.03±12.27) cm/s of the decoction group; the VASP and PSBV of patients in the acupuncture group were significantly faster than those in the decoction group; the differences were statistically significant(P<0.05). The levels of GABA and 5-HT in the combined group were significantly higher than those in the decoction group and acupuncture group, while the levels of IL-1β and TNF-α were significantly lower than those in the decoction group and acupuncture group, with statistically significant differences(P<0.05). The recurrence rate of the combined group was 3.28% after one-month follow-up, which was significantly lower than that of the acupuncture group(18.03%) and the decoction group(13.11%), with statistically significant differences(P<0.05). However, there was no significant difference in the recurrence rate between the acupuncture group and the decoction group after one-month follow-up(P>0.05). There was no significant difference in the incidence of adverse reactions among the three groups of patients(P>0.05). Conclusion Yin-Yang Harmonization Acupuncture Method combined with Qi-nourishing and Heart-calming Formula has significant therapeutic effects on patients with insomnia with deficiency of both the heart and spleen. It can effectively improve the patient’s cerebral blood flow and inflammatory state, regulate neurotransmitters, alleviate clinical symptoms and insomnia, improve sleep quality, and reduce recurrence rates.更多还原